Amgen Life Sciences Regulatory Affairs Job Opening – Apply Online
Amgen Life Sciences Regulatory Affairs Job Opening – Apply Online. Looking for an exciting opportunity for the role SR. ASSOCIATE REGULATORY AFFAIRS in Amgen, check out all the details given the same below.
Job role: SR. ASSOCIATE REGULATORY AFFAIRS
Job Location: Mumbai, Maharashtra
Job description:
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Regulatory Affairs in MUMBAI, INDIA.
The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support a LRR or lead a program under the supervision of an experience Local Regulatory Lead. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
Main Responsibilities:
- Assist in aligning local regulatory requirements with Amgen’s corporate standards.
- Contribute for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With close supervision, implementing the filing plan (MA and Lifecycle maintenance) for the country(ies), where applicable.
- Provide country specific / regional (as applicable) input to and implement regulatory strategies
- Plan and lead local regulatory submissions in compliance with corporate standards and local regulatory requirements
- Provide guidance on local mechanisms to optimize product development and regulatory approval
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Act as the point of contact with regulatory agencies.
WHAT WE EXPECT OF YOU
Qualifications
- Degree in Life Sciences, Pharmacy or Biomedical field and 3-5 years of relevant regulatory experience
- Knowledge of Regulatory principles
- Working with policies, procedures, and SOP’s
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Good knowledge of Indian regulations on new product registration, lifecycle management and clinical trials, SUGAM portal handling.
- General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
- Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
- Understanding of drug development.
THRIVE
WHAT YOU CAN EXPECT OF US
- As we work to develop treatments that take care of others so work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
FOR A CAREER THAT DEFIES IMAGINATION
- In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
EQUAL OPPORTUNITY STATEMENT
- Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join Us
- If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
- Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
- As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Possible interview questions may be asked for SR. ASSOCIATE REGULATORY AFFAIRS in Amgen
- Question: Can you provide an overview of your regulatory experience and how it aligns with the responsibilities of a Senior Associate Regulatory Affairs at Amgen? Answer: Certainly. I have a degree in Life Sciences and have accumulated 4 years of experience in regulatory affairs within the pharmaceutical industry. I’ve been involved in aligning local regulatory requirements with corporate standards, contributing to filing plans, and implementing regulatory strategies. I’ve also gained a comprehensive understanding of regulatory activities and their impact on various projects and processes.
- Question: How familiar are you with Indian regulations on new product registration and clinical trials? Answer: I have a solid understanding of Indian regulations for new product registration, clinical trials, and lifecycle management. I am familiar with the processes and challenges associated with CTAs, MAs, and various lifecycle management activities within the country.
- Question: Can you describe a situation where you had to lead a local regulatory submission? How did you ensure compliance with both corporate standards and local regulations? Answer: Certainly. In my previous role, I led a local regulatory submission for a new product registration. I ensured compliance by thoroughly understanding both corporate standards and local regulations. I collaborated closely with cross-functional teams to gather necessary information, prepare documentation, and ensure that all requirements were met. Additionally, I maintained effective communication with regulatory agencies throughout the submission process.
- Question: How do you stay updated on the evolving regulatory landscape in the pharmaceutical industry? Answer: I actively engage in continuous learning through industry publications, attending regulatory conferences, and participating in relevant training programs. I am a member of professional networks and online forums where regulatory updates are often discussed. This proactive approach allows me to stay informed about changes and trends within the regulatory environment.
- Question: Can you provide an example of a challenging regulatory issue you encountered and how you addressed it? Answer: In a previous project, we encountered unexpected regulatory delays due to incomplete documentation. I addressed this by conducting a thorough review of the requirements and working closely with the team to ensure all necessary documents were prepared accurately and promptly. This proactive approach helped us navigate the issue and expedite the regulatory approval process.
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